The Cancer Leadership Council, representing cancer
patients, health care professionals, and researchers,
appreciates the opportunity to comment on the 2015 Letter
to Issuers in the Federally-facilitated Marketplace
(FFM). We are pleased that some of the standards for
certification of health plans as qualified health plans
(QHP) have been modified from 2014 in a manner that is
responsive to the needs of individuals with cancer and
other serious and life-threatening illnesses.

We have comments on several of the standards for plan
certification, some of which could be strengthened to
ensure that qualified health plans provide adequate
coverage for all, including cancer patients.

As requested in the Letter to Issuers, we have organized
our comments according to the chapter and section of the
letter.

Chapter 2, Section 3. Network Adequacy

We commend the decision of the Centers for Medicare &
Medicaid Services (CMS) to establish a process for
determining network adequacy that does not rely on plan
accreditation and state review. We support the
decision of CMS to undertake a “reasonable access” review
of the lists of network providers and facilities submitted
by issuers. The special focus on oncology providers,
mental health providers, hospital systems, and primary
care providers is also appropriate, but the network
adequacy review cannot stop with these providers.
Cancer patients are obviously most concerned about the
adequacy of oncology provider networks, but they are also
mindful of the need for adequate networks in the other
areas of focus identified by CMS and beyond. Such
provider networks are of critical importance to assure
access to high quality, multi-disciplinary care that
addresses not only cancer treatment but also symptom
management across the continuum of the cancer
experience.

Children with cancer and adults who are diagnosed with
rare cancers may find that their only appropriate care
options are in children’s hospitals or cancer
centers. As part of the network adequacy and
essential community provider review, we urge CMS to
consider network adequacy standards that would protect
these vulnerable patients, essential community provider
designations for children’s hospitals and cancer centers,
and out-of-network provider access that is timely and
accompanied by cost-sharing protections.

We also note that CMS “intends to use information learned
during the network adequacy review process to assist in
its articulation of time and distance or other standards
for FFM QHP networks that CMS intends to reflect in future
rulemaking.” We strongly support this process of
review and refinement of network standards, which over
time should achieve the appropriate balance between
network access and cost. The creation of a search
engine function for consumer searches for particular
providers and provider types is especially important to
cancer patients, including those with rare cancers who may
need access to out-of-network providers.

We note that the Office of Personnel Management (OPM), in
its Multi-State Plan Program Issuer Letter of February 4,
2014, has stated that multi-state plan (MSP) issuers:

“…must have in place
a process to provide timely exceptions to ensure that
consumers who need care from out-of-network providers
(because of rare or complex medical conditions or lack
of in-network providers in a geographic area) can
receive it with reasonable cost-sharing, applying
enrollee costs to the in-network out-of-pocket maximum,
and protection from balance billing.”

It is likely that cancer patients with rare or
difficult-to-treat cancers will find themselves in the
position that OPM describes in its Issuer Letter. We
urge CMS to consider a requirement for QHP issuers that is
comparable to the requirement OPM proposes for MSP
issuers. The cost-sharing protections proposed
by OPM will be essential to making care out-of-network a
realistic possibility for cancer survivors, an important
protection when out-of-network care may represent the
best, or even the only, treatment option for certain
cancer patients.

Chapter 3, Section 1. Discriminatory Benefit
Design: 2015 Approach

The proposed CMS outlier analysis, which will compare
benefit packages with comparable cost-sharing structures
to identify cost-sharing outliers, will strengthen the
agency’s analysis of plans and provide more information
about possible discriminatory benefit designs that should
be corrected. We agree with the recommendation of
CMS that the outlier analysis should begin with (but not
be limited to) inpatient hospital stays, inpatient
mental/behavioral health stays, specialist visits,
emergency room visits, and prescription drugs.

The decision to review plans for outliers based on “an
unusually large number of drugs subject to prior
authorization and/or step therapy requirements in a
particular category and class” and to require revisions of
possibly discriminatory practices is a positive
development for cancer patients for whom quality
treatment may require access to a wide range of
prescription drugs, including combination therapies and a
number of different drugs in a single class over the
course of cancer treatment.

Although the standards for reviewing plans are stronger
than in 2014, we note that CMS has not clearly defined
discriminatory benefit design. Such a definition is
critical to making plan reviews rigorous.

Chapter 3, Section 2. Prescription Drugs

CMS proposes that issuers be permitted to indicate whether
a drug is a “medical drug” covered under a plan’s medical
benefit or a drug covered under the prescription drug
benefit. The agency indicates that this will provide
clarity regarding how drugs are covered and will also
permit issuers to include medical benefit drugs in meeting
the requirement for coverage of one drug in every United
States Pharmacopeial Convention (USP) category or class or
the same number of prescription drugs in each USP category
and class as the state’s essential health
benefit-benchmark plan. We are very concerned that
this proposal would permit issuers to consider medical
benefit drugs and prescription benefit drugs in meeting
formulary adequacy standards. Allowing issuers to
meet formulary standards in this way could limit access to
cancer therapies that are provided incident to a
physician’s service and also hinder access to the most
appropriate therapy for cancer patients. If this
policy is implemented, we urge that the reviews that are
undertaken to protect against discriminatory benefit
design take into account this new means of listing drugs
for the purpose of determining formulary adequacy.

Because CMS will permit but will not require issuers to
identify prescription benefit drugs, consumers will not
necessarily be able to compare medical benefit drug
coverage across plans.

We are pleased that CMS will require issuers to provide a
URL link that will direct consumers to an up-to-date
formulary where they can view covered drugs, tiering, and
cost-sharing for a given QHP. For those consumers
who are already diagnosed with cancer, the availability of
up-to-date formulary information will permit them to make
informed plan choices. Those who are diagnosed with
cancer AFTER making a plan choice will obviously not
benefit from formulary information in the same way.
The situation of those diagnosed after choosing a plan
serves as a reminder of the need for protections to ensure
that formularies are adequate to meet the needs of those
with serious and life-threatening illnesses who need
timely access to pharmaceuticals. In addition, the
formulary comparisons will be hindered if some issuers
identify medical benefit drugs and others do not.

CMS has stated that it will propose by rulemaking that
issuers provide transitions in drug coverage as well as
coverage transitions for other types of care, including
continuity of access to specialists for individuals in the
midst of a course of cancer treatment. In the letter
to issuers, CMS suggests a standard for coverage of a
“transitional fill” of non-formulary drugs to new
enrollees in a health plan. We will comment on the
proposed rule that addresses transitions in care,
providing more detail about the length and nature of
transitions that are necessary to ensure continuity of
care for cancer patients. We note that the proposal
from CMS for transitional fills and access to specialists
will not address issues of care continuity unless patients
are notified that the care they are receiving is
transitional and that they must initiate an exceptions
process immediately to prevent disruptions in care after
the transitional period.

Continued access to cancer specialists and to cancer
medications, which are not readily interchangeable and are
often prescribed according to an individual’s tumor and
molecular profile, may help patients complete their course
of treatment and achieve better outcomes. Preventing
interruptions in care is of critical importance to cancer
patients, and steps must be taken to ensure that the CMS
proposal does not simply delay disruptions in care.

Chapter 3, Section 7. Coverage of Primary
Care: 2015 Approach

We encourage CMS to move forward with rulemaking that
would require plans, or at least one plan at each metal
level per issuer, to cover three primary care office
visits prior to meeting any deductible. We believe
that this coverage standard would contribute to
improvements in survivorship care for cancer patients,
including but not limited to young adult cancer
survivors. Regular monitoring of the late and
long-term effects of cancer treatment and interventions to
address those effects are critically important, yet some
survivors delay this care. Ready access to primary
care may positively influence utilization of such
survivorship services.

Chapter 6, Section 1. Provider Directory

We support the requirement that qualified health plans
make their provider directories available to
consumers. We urge that the directories provide
up-to-date information, so that consumers can make
decisions about providers with assurance that they are
relying on accurate data about network status of those
providers. These decisions have important financial
implications, and there should be no delays in updating
the information in the directories.

Chapter 6, Section 2. Complaints Tracking and
Resolution

The letter to issuers clearly establishes expectations for
QHP performance related to the investigation and
resolution of consumer complaints. The letter
establishes that complaints received directly from
consumers, complaints forwarded by the state, and
complaints forwarded by CMS through the Health Insurance
Casework System must be promptly resolved. In
addition to articulating complaint resolution standards,
CMS has
stated that it will track complaints and use aggregated
data about complaints to enhance oversight of
federally-facilitated marketplaces. We applaud this
effort, which will contribute to improvement of QHPs over
time.

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We appreciate the opportunity to comment on the letter to
plan issuers for 2015.